The basic concept of applying a treating agent to the mouth of a patient is, of course, not new. Jacobs U.S. Pat. No. 4,044,762 discloses incorporation of fluorides in mouthguards. In this patent an athletic mouthguard is disclosed of a generally U-shaped configuration, into which up to about five percent by weight of a fluoride compound has been added, so that a significant amount of fluoride compound is released to the wearer's teeth during repeated uses. The mouthguard itself is made of a polymer that may be formed by heat into an appropriate shape for direct contact with the teeth and gums. There is no attempt to regulate the rate of release, nor is there any recognition that control of elution is possible. In this patent, in fact, there is no method for controlling the rate of release, nor is there any way to restrict the release to a region of interest.
A number of other patents have been granted on products that are used in a person's mouth to, inter alia, release an agent to the patient. Wallshein U.S. Pat. No. 3,205,576 impregnates the elastic bands used in orthodontic treatment, where the release of the impregnated agent is affected by expansion and contraction of the elastic band. Goodson U.S. Pat. Nos. 4,764377 and 4,982,736 both relate to intra-pocket systems where an elastic band is used to retain the therapeutic agent (such as tetracycline in a polymeric matrix) for localized topical treatment. Damani U.S. Pat. No. 5,114,718 to Proctor & Gamble Company uses strips, chips and cones that are inserted for localized topical treatment as well.
Gunther U.S. Pat. No. 4,243,655 employs chewing gum, mouthwashes, dentifrices and other solutions to provide Biotin-antagonists to the mouth. White U.S. Pat. No. 4,554,154 also has a chewable plastic tape carrying a biologically acceptable adhesive that has been encapsulated. Simone etal U.S. Pat. Nos. 5,296,209 and 5,407,661 to Colgate Palmolive Company both relate to edible pet chew products. Taken together these patents disclose the concept of chewable delivery systems. In addition, Lee U.S. Pat. No. 5,437,872 discloses a tablet or lozenge that is held in the patient's mouth. Snipes U.S. Pat. No. 5,135,752 discloses a buccal dosage form which melts in the oral cavity. Both of these last two patents clearly have a disposable system that does not remain in situ and does not offer prolonged release.
Hollander etal U.S. Pat. No. 3,203,097 discloses a dental cushion formed from flannel cloth, a wax-plasticizer and a germicide. There is no concept of controlled release although data showing prolonged test cultures is disclosed. This patent does not contemplate an additive to the artificial dentures. Shepherd etal U.S. Pat. No. 3,618,213 also discloses denture liners made from cast polymers having additives that are gradually released from the article.
None of the prior art specifically teach the concept of a non-adhesive carrier for controlled regional release where the relationship between pore size, molecular weight, concentration and the like are predetermined to achieve specific predetermined times of release. More specifically, none of the references teach the concept of a mouth guard that releases an agent over the nominal time that the mouthguard might be in use, such as the time in which a game may be played, so that a controlled benefit may be obtained in that period of time. The concept of controlling the time of the agent's release is not taught in the prior art.
Accordingly, it is an object of the present invention to provide a device for introducing agents into the mouth of a person for a specific period of time to accomplish a specific, predetermined purpose.
Another object of this invention is to provide a device which releases a treating agent into the mouth without adhesive attachment to the mouth.
Still another specific object of the present invention is to provide a device for releasing a treatment agent into the mouth under conditions where the quantity and duration of release of the agent are controlled to conform to a predetermined treatment.
A specific object of the present invention is to provide a device capable of releasing a treating agent into the mouth for the specific purpose of controlling the release of saliva by the user.
Other objects will appear hereinafter.